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iNSTA XPLOR® P
EUDAMEDClass IVD General (EU MDR)
Ref iNSTA XPLOR® P PA 001Model iNSTA XPLOR P
Identity
- Trade Name
- iNSTA XPLOR® P EUDAMED
- Device Name
- iNSTA XPLOR P PA 001 EUDAMED
- Model / Reference
- iNSTA XPLOR P EUDAMEDiNSTA XPLOR® P PA 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-iNSTAXPLORPF8 EUDAMED
- Basic UDI-DI
- B-iNSTAXPLORPF8 EUDAMED
- EMDN Code
- W0201020204 NEPHELOMETERS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
iNSTA XPLOR® P by STRUmed Solutions Private Limited — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-iNSTAXPLORPF8 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- STRUmed Solutions Private Limited
- EUDAMED SRN
- IN-MF-000023119
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED fd2ff463-b7d2-4aae-8aa9-d3c703ed7c6b 61 fields · synced Jun 19, 2026